Teva Pharmaceuticals USA: Drug Recall
Recall #D-0281-2021 · 02/10/2021
Class II: Risk
Recall Details
- Recall Number
- D-0281-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Teva Pharmaceuticals USA
- Status
- Terminated
- Date Initiated
- 02/10/2021
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,378 vials
Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Product Description
MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Distribution Pattern
Product was distributed nationwide in the USA and Puerto Rico.
Other Recalls by Teva Pharmaceuticals USA
- Class II: Risk 01/18/2022
- Class II: Risk 01/10/2022
- Class III: Low Risk 01/07/2022
- Class III: Low Risk 01/07/2022
- Class II: Risk 12/31/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.